Table 1.
Demographic and Baseline Characteristics (SAS–Combined) and UC-Related Disease Characteristics (FAS) of Patients Enrolled in the Maintenance Phase
| Characteristic | Placebo (n = 10) | Vedolizumab SC (n = 10) | Vedolizumab IV (n = 2) |
|---|---|---|---|
| Age (yr) | 43.6 ± 13.0 | 46.0 ± 15.5 | 54.5 ± 19.1 |
| Male sex | 6 (60.0) | 7 (70.0) | 2 (100.0) |
| Weight (kg) | 58.2 ± 10.6 | 62.9 ± 16.3 | 61.8 ± 6.8 |
| Smoking classification | |||
| Never smoked | 4 (40.0) | 4 (40.0) | 1 (50.0) |
| Current smoker | 0 | 2 (20.0) | 0 |
| Ex-smoker | 6 (60.0) | 4 (40.0) | 1 (50.0) |
| Duration of UC (yr) | 10.3 ± 6.6 | 7.1 ± 4.0 | 8.2 ± 8.0 |
| Prior TNF-α antagonist therapy | 2 (20.0) | 5 (50.0) | 2 (100.0) |
| Concomitant immunomodulator use only at wk 0 | 1 (10.0) | 0 | 0 |
| Concomitant oral corticosteroid use only at wk 0 | 3 (30.0) | 3 (30.0) | 0 |
| Concomitant immunomodulator and corticosteroid use at wk 0 | 6 (60.0) | 7 (70.0) | 2 (100.0) |
| Disease localization | |||
| Left-sided colitis | 3 (30.0) | 4 (40.0) | 1 (50.0) |
| Pancolitis | 6 (60.0) | 5 (50.0) | 1 (50.0) |
| Fecal calprotectin (µg/g)a | |||
| ≤ 250 | 1 (10.0) | 0 | 0 |
| > 250 to ≤ 500 | 1 (10.0) | 0 | 0 |
| > 500 | 8 (80.0) | 10 (100.0) | 2 (100.0) |
| Mayo score | |||
| Mild (Mayo score < 6) | 0 | 0 | 0 |
| Moderate (Mayo score 6–8) | 4 (40.0) | 0 | 0 |
| Severe (Mayo score 9–12) | 6 (60.0) | 10 (100.0) | 2 (100.0) |
| Extraintestinal manifestation (yes) | 0 | 3 (30.0) | 0 |
Value are presented as mean±standard deviation or number (%).
a
Median (minimum–maximum).
SAS, safety analysis set; UC, ulcerative colitis; FAS, full analysis set; SC, subcutaneous; IV, intravenous; TNF, tumor necrosis factor.